FDA Rejects Gefapixant NDA for Chronic Cough
The application includes data from the two phase 3 studies, which evaluated the efficacy and safety of gefapixant in adults with refractory or unexplained chronic cough for at least 1 year.
Respiratory Diseases/Disorders
Respiratory Droplets From a Person Walking Down Stairs Increases Risk for Infection
Investigators conducted a study that compared the risk for infection from the dispersion of respiratory droplets from a person walking downstairs vs upstairs.
Ryaltris Nasal Spray Approved for Seasonal Allergic Rhinitis
Ryaltris is a metered, fixed-dose nasal spray that delivers 665mcg of olopatadine hydrochloride and 25mcg of mometasone furoate in each spray.
Shorter Antibiotic Course Safe, Effective for Uncomplicated Childhood CAP
The randomized, double-blind, placebo-controlled study included a total of 380 patients aged 6 to 71 months with nonsevere CAP.
Oral vs IV Antibiotics for Pseudomonas aeruginosa Infection in Patients With Cystic Fibrosis
Researchers conducted a study to compare the effects of intravenous vs oral antibiotics therapy in patients with a pulmonary infection caused by Pseudomonas aeruginosa secondary to cystic fibrosis.
Novel Immunomodulator Gets Orphan Drug Status for Sarcoidosis
Results from a phase 1/2 showed that ATYR1923 was safe and well tolerated.
N95 Respirators vs Surgical Masks for Protection Against Viral Respiratory Illnesses
Researchers conducted a meta-analysis to determine the effectiveness of N95 respirators vs surgical masks in protecting against viral respiratory illness transmission.
Additional Data Support Efficacy of Molnupiravir for Mild to Moderate COVID-19
The phase 3 MOVe-OUT trial included all 1433 at risk adults with mild to moderate COVID-19 and symptom onset within 5 days of randomization.
Yutrepia Gets Tentative Approval for Pulmonary Arterial Hypertension
Yutrepia is an inhaled dry powder formulation of tresprostinil delivered through a palm-sized device.
Alvelestat Designated Orphan Drug for Alpha-1 Antitrypsin Deficiency
Alvelestat is a novel, oral small molecule designed to inhibit neutrophil elastase.
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